Sub-Investigator

Valkyrie Clinical Trials (VCT) , a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! We are actively hiring a Sub-Investigator to supportour Valkyrie Clinical Trials Denver, Colorado site. LOCATION : Onsite FLSA : Exempt HOURS : Monday to Friday, Day Shift, 40 hours per week COMPENSATION : $130,000 to $150,000 per year (depending on experience)

ESSENTIAL JOB FUNCTIONS:

Represent Flourish Research in a professional and courteous manner (verbal, written,and inappearance) during all interactions with sponsors, physicians, physicians' office personnel, participants,Flourish Research employees,contract personnel, as well as any other person(s) when carrying out tasksand responsibilities. Ensure the maintenance of confidentialityof participant informationby team members asappropriateand as bound by Confidentiality Agreements withFlourish Research, betweenFlourish Research and sponsors/CROs,and betweenFlourish Research and other entities while abiding by HIPAA regulations. Assume overall responsibility for the success ofFlourish Research under the direction of, as applicable, the CEO, General Manager,Site Director, andMedical Director. Possess a thorough knowledge and understanding of the requirements of each study protocol. Determinewhether inclusion/exclusion criteriaare applicableto the study population. Follow each study's randomization procedures. Maintain protocol compliance,includingimplementingonlyprotocol deviationsor changesapprovedby the sponsor/CRO and IRB (except toeliminateimmediate hazards to the participant). Review the inclusion/exclusion criteria, procedures, scheduled visits, end point criteria,and investigationalproductuse with the research team. Ensure that a qualified physicianis responsibleforall trial-related medical decisions. Assess participant compliancewith protocolrequirementsand follow-up visits. Assessparticipantresponse to therapy. Evaluate adverse experiences anddetermineseverity andrelationshipto the investigational product. Ensure that medical care is provided to a participant for any adverse event(s). Document and report all serious adverse eventsimmediately, and within 24hrsof becoming aware of the eventto the sponsor/CRO and IRB. Obtain signed and dated informed consent from thestudyparticipant or participant's legal representative prior toinitiatingany study-related procedures. Inform the participant or legal representative about all aspects of the clinical trial. Document that informed consent has been obtained from the participant or legal representative. Always consider participant safety and welfare the priority. Ensure the accuracy, completeness, legibility, and timeliness of case report forms (CRFs). Explain any discrepancies between source documents and case report forms (CRFs). Endorse changes or corrections to a case report form (CRF). Review and sign data management queries and case report forms (CRFs)in a timely manner. Document deviations from the approved protocol. Document and explain premature unblinding of the investigational product(s). Conduct, when necessary,clinical interviews and administer a variety of psychological tests, clinical rating scales, and/or diagnostic assessments. Evaluate results through scoring and documented findings inparticipants’medical records andFlourish Research CTMS, eDocs, Source/EMR. Ensure validity and reliability when administering tests/scales/assessments bycomplying withestablished standards foradministering alltesting and per sponsors’ protocols. Ascertainand documentthe reason for a participant’s prematurestudywithdrawal. Comply withwritten procedures to document changes to data and/or case report forms (CRFs). Read the current investigator’s brochure, product insert, or othersourceinformation. Develop thorough knowledge and familiarity with the use of the investigational product(s). Collaborate closely with pharmacy, nursing,administration,and all study personnel toensure excellence in study conduct andpatientcare. AttendInvestigator meetings, SIVs,monitoringvisits,andindustry conferences asneeded. Perform other administration duties asneeded ordirectedby, asappropriate, the General Manager, Site Director, or Medical Director.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

Work is normally performed in a typical interior clinical/office work environment. Exposuretohumanbodilyfluids; Laboratoryprocedurestoobtainspecimensandprocessingofspecimens; Participant/PatientCare; Dailycomputeruse; Local travelrequiredtoensure coverage at allsites, ifmultiple local locations; Occasional travel for meetings and conferences; Abilitytoproperlyliftthirty-fivepoundsandoccasionallymorethanthirty-fivepounds.

MINIMUMREQUIREMENTS:

Education:Medical (M.D.) degree, Doctor of Osteopathy (D.O.), Doctor of Nursing Practice (D.N.P.),Physician’sAssistant (P.A.),AdvancedPracticeNurse Practitioner(APRN),Doctor of Psychology (PsyD). Experience:A minimum of 2 years’ experience in performing physicals, assessing, and treating patients. 1-3+ years' experience within the field ofoncologyclinical research;early phase oncologyclinical trial experience preferred. Knowledge and Skills: Strong supervision, interpersonal,and communication skills. Able to make good, sound decisions under stressful situationsand time constraints. Must be able to make sound medical judgments on the health and safety of subjects duringtheir participation in a clinical research study. Maintain professional and technical knowledge by attending educational workshops in other activities tomaintaincontinuing medical education requirements. Review professional publications. Mustpossessexceptionalorganizationalandplanning skills and good documentation skills. Must have good conflict resolution skills and be committed to quality and honesty. In-depth knowledge of the clinical research process, including Good Clinical Practices. Flourish Research offers an excellent comprehensive benefits package to include:Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays. Flourish Research is an equal employmentopportunityemployer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees. #J-18808-Ljbffr Flourish Research